Mechanistic Pathways of Mindfulness Meditation in Post-traumatic Stress Disorder.

The purpose of this study is to find out how meditation influences certain systems in the body: nervous system, hormonal system, and respiratory system. Another purpose is to see how meditation may help improve post-traumatic stress disorder symptoms.

Study Overview

• Status: Completed
• Conditions: Post-Traumatic Stress Disorders
• Intervention / Treatment: Behavioral: Slow Breathing; Behavioral: Meditation; Behavioral: Meditation and slow breathing; Behavioral: Sitting Quietly

Detailed Description

This study requires nine visits to the clinic: one screening visit, one baseline visit, six training sessions, and one endpoint visit. There will be approximately 100 people enrolled in this study who will be randomly allocated to one of four groups: a slow breathing group, a meditation group, a meditation plus slow breathing group and a sitting quietly group.

Participants will undergo a telephone screening, a screening visit, baseline visit, six intervention visits (once per week for six weeks), and one endpoint visit (one week after the final training visit). A telephone screening and screening visit will ensure participant eligibility. The screening visit included structured clinician interviews on PTSD symptoms and other mental health disorders, completion of questionnaires, and receipt of home saliva collection kit. At the baseline visit, electrodes will be attached to measure the electrical activity of head, chest, skin, and respiration and blood pressure during a computer task. Intervention visits include slow breathing, meditation, mediation and slow breathing, or sitting quietly depending on which group the participant is allocated to. Breathing rates and other electrical activity of the body will be measured also. Breathing rate will be measured with an elastic band that is placed around the chest. Electrical activity will be measured by the electrodes that will be placed on the scalp, chest and skin. The endpoint visit will be exactly the same as the baseline visit.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Combat veteran (defined by a score of ≥7 on the Combat exposure scale)
• Chronic PTSD diagnosis
• Age range (25-65 years)
• Both genders
• Good general medical health
• Stable dose of medications for concurrent stable medical conditions for at least 4 weeks prior to start of the study.
• Willing and able to provide informed consent.

Exclusion Criteria:

Significant chronic medical illness including:

• current cancer treatment,
• unstable angina,
• recent myocardial infarction,
• current or past history of stroke,
• transient ischemic attack,
• congestive heart failure,
• chronic renal or hepatic failure,
• hypothyroidism

Psychiatric or behavioral illness including:

• schizophrenia,
• schizoaffective disorder,
• bipolar disorder,
• psychotic disorder (not including transient dissociative states or flashbacks associated with PTSD re-experiencing symptoms),
• any DSM-IV cognitive disorder,
• current delirium,
• psychiatric instability or situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to the patient or others.
• Substance dependence disorder within 3 months of the study or
• current substance use other than alcohol (no more than 2 drinks/day by self-report)
• Sexual assault as primary PTSD event/s.
• Planning to move from the area in the next year.
• Prior or current meditation practice.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Slow Breathing Group	Behavioral: Slow Breathing; The slowed breathing group will be trained on a breathing device, RESPeRATE, designed to reduce respiratory rate.They will practice with RESPeRATE once a week (for 6 weeks) in the laboratory with the research staff.
EXPERIMENTAL: Meditation Group	Behavioral: Meditation; The Mindfulness Body Scan meditation will be used for the mindfulness meditation group.Participants will be trained once a week (for six weeks) in the laboratory by the research staff.
EXPERIMENTAL: Meditation and Slow Breathing Group	Behavioral: Meditation and slow breathing; A structured Mindfulness breathing will be guided by the research staff during the lab trainings. The participant will sit upright and attempt to focus attention on his or her own breath as it passes the opening of the nostrils or on the rising and falling of the abdomen or chest. Whenever attention wanders from the breath, the participant will simply notice the distracting thought and then let it go as attention is returned to the breath. Training will be given once every week for 6 weeks.
PLACEBO_COMPARATOR: Sitting Quietly Group	Behavioral: Sitting Quietly; The SQ control group's "intervention" will include sitting quietly and listening to a neutral-content book on tape to serve as a time and attention control at each laboratory session. They will also be asked to sit quietly at home daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Attentional Network Task: conflict effect score	Change from Baseline to Endpoint visit (one week after last training visit)
Awakening cortisol values	Change from Baseline to Endpoint visit (one week after last training visit)
Post-traumatic stress disorder checklist-hyperarousal score	Change from Baseline to Endpoint visit (one week after last training visit)

Secondary Outcome Measures

Outcome Measure	Time Frame
Intrusive Thought Scale	Change from Baseline to Endpoint visit (one week after last training visit)
EEG event-related negativity during Attentional Network Task	Change from Baseline to Endpoint visit (one week after last training visit)
Heart rate	Change from Baseline to Endpoint visit (one week after last training visit)

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); Oregon Clinical and Translational Research Institute
• Investigators: Principal Investigator: Helane Wahbeh, ND, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: October 22, 2008
• First Submitted That Met QC Criteria: October 22, 2008
• First Posted (ESTIMATE): October 24, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 13, 2015
• Last Update Submitted That Met QC Criteria: July 9, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: K01AT004951-01 (NIH); 4692